Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
NXX is the FDA product code for Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus, a class I device type, regulated under 21 CFR 866.3700. FDA's definition for this code reads: "The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6)". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- NXX
- Device name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
- FDA definition
- The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).
- Regulation
- 21 CFR 866.3700
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 1
Clearances, product code NXX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 2 |
| 2012 | 1 |
Applicants with the most clearances
Product code NXX| Applicant | Clearances |
|---|---|
| Advandx, Inc. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NXX.
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